VICL Slumps, FDA Greenlights SRPT's DMD Drug, Domino Effect On PTCT

(RTTNews) - Shares of NovaBay Pharmaceuticals Inc. (NBY) rose more than 8% on Monday after the company announced that Auriclosene Irrigating Solution demonstrated statistically significant and clinically meaningful results in a phase 2b study.

The phase 2b study tested Auriclosene Irrigating Solution in the prevention of urinary catheter blockage and encrustation in subjects with chronic indwelling urinary catheters who have repeat history of blockage.

Of the approximately 300,000 patients in the U.S. with indwelling catheters, about 100,000 chronically suffer from blockage and encrustation, noted the company.

NBY closed Monday's trading at $3.79, up 8.91%.

Shares of Sarepta Therapeutics Inc. (SRPT) surged as much as 99% on Monday, following FDA's accelerated approval of EXONDYS 51 for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

Exondys 51, also known generically as eteplirsen, becomes the first DMD treatment to be approved in the U.S. The drug targets dystrophin deficiency, the underlying cause of DMD.

Although EXONDYS 51 was voted down by an FDA panel on April 25, 2016, the FDA postponing its decision date of May 26, 2016, raised hopes of approval.

Now that it is approved, the U.S. commercial launch of EXONDYS 51 is planned to commence immediately.

SRPT touched a high of $56.18 on Monday, before closing the day's trading at $48.94, up 73.85%.

The FDA approval of Sarepta Therapeutics Inc.'s (SRPT) EXONDYS 51 for the treatment of Duchenne muscular dystrophy had a domino effect on PTC Therapeutics Inc. (PTCT) on Monday, with its shares jumping as much as nearly 29%.

PTC Therapeutics has also been seeking FDA approval for its DMD drug Translarna. In February of this year, the FDA refused to accept the NDA for Translarna for review, stating that the application was not sufficiently complete to permit a substantive review.

However, Translarna has been available in the European Union since December 2014. The drug was given conditional approval by the European Medicines Agency for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients aged five years and older in August 2014.

PTCT closed Monday's trading at $10.99, up 20.64%.

TherapeuticsMD Inc.'s (TXMD) New Drug Application for Yuvvexy, the proposed treatment of moderate-to-severe vaginal pain during sexual intercourse, a symptom of vulvar vaginal atrophy in postmenopausal women, has been accepted for review by the FDA. The FDA's decision date for Yuvvexy is set for May 7, 2017.

Yuvvexy, also known as TX-004HR, is an applicator-free vaginal estradiol softgel capsule that is being developed under 505(b)(2) regulatory pathway.

TXMD closed Monday's trading at $6.67, down 1.19%.

Shares of Vical Inc. (VICL) slumped more than 22% on Monday as its phase II study of investigational cytomegalovirus vaccine ASP0113 in kidney transplant patients failed to meet the primary endpoint.

Vical and Astellas Pharma signed exclusive license agreements for ASP0113 in July 2011.

According to the company, the trial did not meet its primary endpoint, which was the proportion of patients having CMV viremia defined as a plasma viral load of = 1000 IU/mL by central laboratory assay through one year after first injection of ASP0113.

Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups - i.e. ASP0113 and placebo.

VICL closed Monday's trading at $3.00, down 22.28%.

Windtree Therapeutics Inc.'s (WINT) AEROSURF, a combination drug/device candidate, for the treatment of premature infants with respiratory distress syndrome, has been granted Fast Track designation by the FDA.

AEROSURF is under phase IIa and phase IIb trials.

The phase IIa trial is evaluating AEROSURF in 32 premature infants 26 to 28 week gestational age receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS). The company anticipates completing enrollment in September and releasing top-line results of this trial in late September or early October 2016.

The phase IIb trial is evaluating AEROSURF in premature infants 26 to 32 weeks gestational age receiving nCPAP for RDS. Top-line results from this study are expected in the first quarter of 2017.

WINT closed Monday's trading at $2.20, down 1.79%.